What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which can cause side effects like nausea, vomiting, diarrhea, muscle cramps, and loss of appetite. Memantine, an NMDA receptor antagonist, may lead to dizziness, headache, confusion, and constipation. While specific side effects for tau protein binding agents like [18F]PI-2620 used in PET imaging are not detailed, imaging agents generally may cause mild reactions such as injection site pain or allergic reactions. Patients should discuss potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on symptomatic relief and slowing disease progression. Cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine are commonly used to enhance cholinergic transmission. Memantine, an NMDA receptor antagonist, is another approved treatment that helps manage symptoms. Recently, aducanumab, a monoclonal antibody targeting amyloid-beta plaques, received FDA approval, marking a significant step in disease-modifying therapies. While these treatments do not directly relate to tau protein binding for PET imaging, they represent the current landscape of FDA-approved Alzheimer's therapies.

What other types of research exist?

Promising alternatives to [18F]PI-2620 for PET imaging in Alzheimer's Disease patients include amyloid PET imaging agents, which show increased binding in a significant subset of patients with AD and may correlate with cognitive impairment. Additionally, quantitative EEG and investigational biomarkers like alpha-synuclein deposition in peripheral tissues are being explored as potential diagnostic tools.

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PET Imaging Agent

[18F]PI-2620 PET Imaging for Alzheimer's Disease

Verified Trial

Phase 3

Recruiting

Led By Alireza Atri, MD, PhD

Research Sponsored by Life Molecular Imaging Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at autopsy, until study completion with an average of 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a brain scan that uses a special substance to detect harmful proteins in people with Alzheimer's disease.

Who is the study for?

This trial is for men and women over 50 with Alzheimer's or terminal conditions like end-stage dementia, who are not on aggressive life-sustaining treatments, have a life expectancy of ≤1 year, can lie in a PET scanner, and consent to brain donation after death. Pregnant women or those without proper contraception are excluded.

What is being tested?

[18F]PI-2620 is being tested for its ability to detect tau protein deposits in the brain using PET imaging. Participants will be compared with post-mortem histopathology results to assess the accuracy of this method in living subjects versus autopsy findings.

What are the potential side effects?

Since [18F]PI-2620 is used for imaging rather than treatment, typical side effects associated with medications may not apply here. However, participants may experience discomfort from lying still during the PET scan or potential reactions related to the imaging process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at autopsy, until study completion with an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at autopsy, until study completion with an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at autopsy, until study completion with an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative)

Secondary study objectives

Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0, B1 or B2 = negative)

Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of AD neuropathologic change (ADNC) ('No' or 'Low' levels of ADNC = negative)

Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of ADNC ('No', 'Low' or 'Intermediate" levels of ADNC = negative)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PI-2620 PET ScanExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]PI-2620

2018

Completed Phase 2

~150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and tau protein imaging agents. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, work by increasing levels of acetylcholine in the brain, thereby improving cognitive function and alleviating some symptoms of AD. Tau protein imaging agents like [18F]PI-2620 are used in PET scans to detect tau deposits, which are indicative of AD. This imaging technique aids in early and accurate diagnosis, allowing for timely and effective treatment. Understanding these mechanisms helps in choosing appropriate treatments and monitoring disease progression, ultimately improving patient outcomes.